Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The goal of this clinical trial is to assess the effect of using baclofen along with conventional treatment in improving GERD symptoms. It will also assess the safety of drug baclofen by recording the patient reported adverse events. The main questions it aims to answer are : Does drug baclofen along with conventional treatment has any effect on patients with GERD symptoms? What medical problems do participants have when taking drug baclofen? Researcher will compare drug baclofen along with conventional treatment to a control group taking placebo along with conventional treatment. Participants will: Take drug baclofen 10 milligrams or placebo three times daily along with conventional treatment for 4 weeks. They will visit the hospital after 4 weeks. Their symptoms will be assessed via validated GERD Q questionnaire at baseline and after 4 weeks. Additionally, patient reported adverse events will be documented.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 and above

• Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks

Locations
Other Locations
Bangladesh
Dhaka Medical College
RECRUITING
Dhaka
Contact Information
Primary
Adnan Imtiaj Rahul, MBBS
adnanimtiaj@gmail.com
+8801311286376
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
Active_comparator: Baclofen
Tablet baclofen 10mg three times will be given along with conventional treatment
Placebo_comparator: Placebo
Tablet placebo three times daily along with conventional treatment
Sponsors
Leads: Adnan Imtiaj Rahul

This content was sourced from clinicaltrials.gov